Confirmation of negative strep testing

As a previous long time CLIA surveyor, a "should" comment is a recommendation.  If you are inspected by CLIA, an inspector should not cite a deficiency if you're not confirming negative results.  If they did, I would contest it.

I'm not sure how Joint Commission, CAP, or COLA views the "should" statement.  They have to meet the CLIA standards, but can be more strict in their requirements.  

Who are you inspected by?  I know Joint Commission surveys recommendations from the manufacturers as requirements.  We are Joint so we would be required to send each negative for a culture.  Unsure about the others.

So here is a slightly different approach. Not saying it's guaranteed to 'get by' an accreditation.
For quite some time related to antigen strep testing negative results, we've taken the path that in the lab SOP, it's a recommendation to have the clinical/MD/provider decide to send out or not for confirmation.
We used to 'highly recommend' or tip towards requiring confirmating negatives in Pediatrics.
But we did not audit for 'sending out' for confirms.
One thing to note unless it's changed recently regarding cost is that even though the CPT codes have always been different, we didn't/don't (not sure) get reimbursed for the rapid/antigen test if a confirm was sent out.

For what it's worth.

Hi
Most rapid Ag Strep tests I believe have this disclaimer.  Please review "RED- BOOK" Pediatric Requirements for negative rapid strep reflexing. 
 
Our organization reflexes all negative tests on patients less than 25 years old to a PCR test (this has replaced an actual culture).  This is due to the potential sequalae younger patients can get if strep left untreated. Patient's older is at the discretion of the provider. 
Good luck!

We reflex-culture negatives for patients 18 and under. 19 and over negatives reflex to culture only by MD request. 

JHACO and CAP interpret "should" and "recommended" in the manufacturer literature as "required". 

CAP's Inspector Team Member Training (January 31, 2023) module includes basic definitions of the words "Must" and "Should". 

My site got cited for this by an inspector last year.  It is our policy that all negatives get sent for confirmation, however when the inspector asked to see evidence of this, there were a couple of one-off instances in which the negatives were not sent.  When we looked into it further, the samples were not sent for confirmation because the pediatric patient wound up being positive for something on a Respiratory Panel and the doctor agreed he did not feel the confirmation was warranted.
We submitted a challenge to CAP and succeeded based on the fact that the POC.04575 regulation states for evidence of compliance is only a policy showing that this is the defined process, not that there is monitoring of the policy matching procedure.   Our policy did have this requirement stated and therefore we were able to expunge this citation.